Kornimate/medical-research-clean huggingface dataset:
stress incontinence trial with elitone device

Conditions: Stress Urinary Incontinence

Summary: this is a randomized controlled study in which subjects are assigned to either a treatment group or a control (sham) group. pre- and post-study outcome measures evaluate the change in incontinence episodes on women with mild-moderate stress urinary incontinence.

the elitone device delivers electrical muscle stimulation to pelvic floor muscles through a disposable surface electrode shaped to fit the perineal region. in typical use women self-administer treatment 20 minutes per day, 5x per week, for 6-12 weeks. elidah is initiating a prospective, randomized clinical study to demonstrate device efficacy. the study expands a similar pilot to 60 subjects, adds a control arm (sham device) and includes additional outcome measures. like the earlier study, subjects will self-administer treatment over multiple weeks while maintaining daily logs of their treatment and incontinence symptoms. this is a home-use study, which does not require clinic visits. accordingly, this allows subject recruitment from across us.

Eligibility criteria:
inclusion criteria: predominant mild-moderate stress incontinence symptoms as determined by self-reported typical number of accidents of 1 per 24 hours or more. exclusion criteria: * severe incontinence as determined by self-reported \>5 accidents in 24-hr period * currently pregnant, may be pregnant, attempting to become pregnant, or delivery within previous 6 weeks * implanted cardiac device, untreated cardiac arrhythmia or suffer from other heart problems. * cancer, epilepsy or cognitive dysfunction * vaginal or pelvic surgery within previous 6 months * complete denervation of the pelvic floor * history or symptoms of urinary retention, extra-urethral incontinence, overflow incontinence * active urinary tract infection (uti) or history of recurrent utis (more than three in a year) * recurrent vaginitis (bacterial/fungal) * pelvic pain/painful bladder syndrome * underlying neurologic/neuromuscular disorder * severe obesity as defined by bmi \>= 35 * chronic coughing * impaired decision making, drug or alcohol dependence, or suicidal thoughts. * anyone who lacks the capacity to consent for themselves or who requires a legal representative to give informed consent.
efficacy and safety of a hyaluronic acid-based vaginal moisturizer medical device to ease symptoms of vaginal dryness

Conditions: Vaginal Disease

Summary: this study evaluates the efficacy and safety of a new hyaluronic acid-based vaginal moisturizer gel to ease symptoms of vaginal dryness compared to a commonly used marketed vaginal moisturizer (cumluade hidratante interno®).

this is a prospective, multicenter, randomized, controlled, double-blind clinical investigation to evaluate the safety and efficacy of a new hyaluronic acid-based vaginal moisturizer gel (medical device class iib) in women with symptoms of vaginal atrophy and dryness, compared to a commonly used marketed vaginal moisturizer in gynecology clinics (cumluade hidratante interno®), with a 1-month follow-up. the participants will apply the single dose of vaginal moisturizer 3 times per week, every other day, preferably in the evening. the investigators will monitor the evolution of vaginal symptoms, vaginal health using the vaginal health index (vhi), sexual function using the female sexual function index (fsfi) questionnaire, and the safety and tolerability of the new class iib medical device.

Eligibility criteria:
inclusion criteria: * women over 18 years of age who manifest subjective symptoms of vaginal dryness (dryness, itching, burning/stinging and dyspareunia). * in the case of postmenopausal women, they must have a diagnosis confirmed by the gynecologist of the presence of signs of vulvovaginal dryness/atrophy (vaginal health index score \<15). * patients who have not used any topical treatment, moisturizer or vaginal lubricant for at least 7 days prior to the start of the study and agree not to use it during the study period. * patients who agree to participate and sign the informed consent form. exclusion criteria: * pregnant women * malignant neoplasm within 5 years prior to study entry (except for treated basal cell/squamous cell carcinoma of the skin). * genital bleeding. * treatment with vaginal or systemic estrogens in the 3 months prior to study inclusion or during the study period. i said above * subjects with illness or other medical condition that, in the investigator's opinion, would compromise participation or could lead to hospitalization during the study. * clinical evidence of acute infection that requires treatment (syphilis, herpes simplex, human papilloma virus, gonorrhea, chlamydia, lymphogranuloma venereum, etc.); clinical evidence or history of chronic infectious disease (i.e., tuberculosis), with the exception of hpv-carrying women with no lesions. * psychosis, schizophrenia, mania, depressive disorders, history of suicide attempt or suicidal ideation, or any other psychiatric illness (except intermittent anxiety). * known allergy to the components of the investigational product or its excipients. * drug or alcohol abuse in the 12 months prior to the start of the study. * participation in an interventional clinical study or administration of any investigational agent within the previous 30 days. * patients with low expectation of compliance with the study protocol.

Keywords: vaginal disease vaginal dryness vaginal atrophy
systemic treatments for alopecia areata registry

Conditions: Alopecia Areata; Alopecia Totalis; Alopecia Universalis; Hair Loss; Hair Diseases; Alopecia; Alopecia Drugs; Autoimmune Diseases

Summary: a multicenter prospective registry (sta2r) is conducted to assess systemic treatments for alopecia areata, focusing on effectiveness, safety, and long-term outcomes.

rationale: alopecia areata (aa) is a dermatological disorder characterized by non-scarring hair loss, significantly affecting the quality of life of patients. while some patients experience spontaneous hair regrowth or respond well to localized treatments, patients with moderate-to-severe aa represent a subgroup that requires more extensive systemic therapies for effective management. currently, the clinical management of moderate-to-severe aa is primarily based on expert opinions. there is a lack of research on systemic treatments for moderate-to-severe aa, comprising only a small number of randomized controlled trials and observational studies. furthermore, there is a clear absence of long-term, prospective, and comparative data on these therapies. most conventional systemic treatments for aa are prescribed off-label, underlining the importance of gaining a more comprehensive understanding of their effectiveness and safety. therefore, a long-term prospective registry is conducted. this registry will evaluate the real-world utilization of systemic treatments in aa patients, aiming to provide valuable insights into the effectiveness, safety, and long-term outcomes of these therapies. by collecting and analyzing such data, this registry endeavors to contribute to evidence-based clinical management, ultimately improving care for aa patients. objective: the aim is to establish a comprehensive cohort of aa patients receiving systemic treatments, with the primary objective of assessing the short- and long-term effectiveness and safety of various systemic treatments for aa. study type: this is a long-term multicenter prospective, observational, non-interventional registry. study population: all adult aa patients starting systemic treatment, who are willing to provide voluntary informed consent prior to inclusion in the registry and comply with the requirements of the registry.

Eligibility criteria:
inclusion criteria: * diagnosed with alopecia areata; * starting/using a systemic treatment for alopecia areata; * informed consent for registry participation obtained from patient and/or caretaker. exclusion criteria: * not sufficiently capable of understanding the dutch language; * not willing to participate.

Keywords: alopecia areata alopecia totalis alopecia universalis systemic treatment registry
application of artificial intelligence for early diagnosis of gastric cancer during optical enhancement magnifying endoscopy

Conditions: Artificial Intelligence; Optical Enhancement Endoscopy; Magnifying Endoscopy

Summary: previous prospective randomized controlled study demonstrated higher accuracy rate of diagnosing early gastric cancers by magnifying image-enhanced endoscopy than conventional white-light endoscopy. nevertheless, it is difficult to differentiate early gastric cancer from noncancerous lesions for beginner. we developed a new computer-aided system to assist endoscopists in identifying early gastric cancers in magnifying optical enhancement images.

gastric cancer is the third most common cause of cancer-associated deaths worldwide especially in asia.early detection and treatment would cure the disease with 5-year survival rate greater than 90%.however, the sensitivity of conventional endoscopy with white-light imaging (c-wli) in diagnosis of early gastric cancers (egcs) is merely 40%. magnifying image-enhanced endoscopy (iee) techniques such as magnifying narrow band imaging (m-nbi) have been developed and 2 rct report that white-light imaging combine with m-nbi can increase the sensitivity to 95%. the strategy that using white-light imaging to detect the suspicious lesion and using m-iee techniques to make a diagnosis of early gastric cancer is recommend in screening endoscopy. optical enhancement (oe) which is one of the m-iee techniques was developed by hoya co. (tokyo, japan) . this technology combines digital signal processing and optical filterers to clear display of mucosal microsurface (ms) and microvessel (mv). the advantage of oe is to overcome the darkness of nbi which leads to less usefulness for detect-ability in the full extended gastrointestinal lumen.nevertheless, it is difficult to differentiate early gastric cancer from noncancerous lesions for beginner, and expertise with sub-optimal inter-observer agreement is essential for the use of m-iee. nowadays, artificial intelligence (ai) using deep machine learning has made a major breakthrough in gastroenterology, which using gradient descent method and backpropagation to automatically extract specific images features. the diagnostic accuracy in identifying upper gastrointestinal cancer was 0.955 in c-wli . polyps can be identified in real time with 96% accuracy in screening colonoscopy. ai show an outstanding application in detection and diagnosis. this study aims to develop a m-oe assistance model in the diagnosis of egcs by distinguishing cancer or not.

Eligibility criteria:
inclusion criteria: * patients receive optical magnifying oe endoscopy examination exclusion criteria: * patients with advanced cancer, lymphoma,active stage of ulcer and artificial ulcer after esd were excluded.
impact of color correcting lenses on color vision deficiency

Conditions: Color Blindness; Color Vision Defects; Color Blindness, Green; Color Blindness, Red

Summary: to demonstrate improved color vision in subjects with color vision deficiencies while wearing color-correcting lenses and after color-correcting lense use.

the long term objective of this study is to extend upon research demonstrating improvements in color vision deficiencies (cvds) while wearing color-correcting lenses (ccls) and after wearing ccls. recordings of brainwaves and eye-waves will be made to assess the retina, optic nerve and brain in order to localize where adaptive changes in the visual system are occurring in response to wearing ccls.

Eligibility criteria:
inclusion criteria: * no reported history of eye, systemic or ocular disease * va of 20/30 in each eye * hereditary color vision deficient (cvds) verified by failing scores on the red-green anomaloscope (outside system normal range) and ishihara testing (3 or more errors on 14 testable plates) * color vision normal (cvns) verified by passing red-green anomaloscope (outside system normal range) and ishihara testing (3 or more errors on 14 testable plates) exclusion criteria: * reported use of sleep-inducing or wakefulness drugs

Keywords: color-correcting lenses
iressa combined with radiotherapy & gemcitabine as first-line treatment in locally advanced pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the primary objective of the trial is to identify the dose of gemcitabine given as a 2-hour intravenous (iv) infusion that can be administered in combination with zd1839 250 mg once daily and a standard course (45 grays \[gy\]) of radiotherapy in patients with locally advanced, unresectable pancreatic cancer.


Eligibility criteria:
inclusion criteria: * histologically confirmed pancreatic cancer (aspiration biopsy by fine needle \[paaf\] by use or biopsy guide by eco-ct). it is mandatory the diagnostic by use and will recommend the aspiration biopsy with this technique * tumoural volume by tac \< 500 cc * aged 18 to 75 years inclusive * eastern cooperative oncology group (ecog) performance status (ps) £ 1 * life-expectancy of more than 12 weeks * women of child-bearing potential must be willing to practice reliable methods of birth control to prevent pregnancy exclusion criteria: * previous radiotherapy or chemotherapy for malignant disease * other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ * in the opinion of the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease) * absolute neutrophil count (anc) less than 1.5 x 109/litre (l), platelets less than 100 x 109/l or haemoglobin less than 9 mg/dl; prothrombin time (pt) less than 50%; serum bilirubin greater than 2.5 times the upper limit of reference range (ulrr; creatinine clearance less than 45 ml/min; alt or ast greater than 2.5 times the ulrr * active dermatoses (e.g. psoriasis, eczema) * concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, or drugs with known corneal toxicity * known, severe hypersensitivity to zd1839 or any of the excipients of this product

Keywords: pancreatic cancer egf-r
exploring learning and unlearning of fear

Conditions: Healthy Individuals

Summary: the present study investigates the effect of d-cycloserine on learning and unlearning of fear in healthy humans and its underlying effect on the amygdala. as a second objective, the effect of genotype on fear learning will be studied.

a growing body of evidence suggests that the extinction of fear is mediated by the n-methyl-d-aspartate (nmda) receptor activity in the basolateral amygdala. intra-amygdala infusions of antagonists of this glutamate receptor in small animals (eg: rats, mice) have demonstrated a blockage of fear acquisition and extinction. agonists, on the other hand, facilitate conditioned fear extinction. the animal studies are all based on the simple fear learning paradigm of conditioning. however, it is not clear that human anxiety disorders are based on prior conditioning encounter. therefore it is important to disentangle the effect of dcs on acquisition and extinction in the context of a simple learning paradigm, particular its effect on the human amygdala.

Eligibility criteria:
inclusion criteria: * no axis i diagnosis compatible with the dsm-iv by means of a structured diagnostic interview * right-handed exclusion criteria: * current psychopharmacological or psychological treatment. * the presence of a physical/medical condition that may interfere with the study. * a contraindication for the use of dcs * pacemaker, medication pump (such as insulin pump), hearing aid, removable prosthodontics * metal in or on body (such as acupuncture needles, artificial limbs, stents, metal splints, clips, implanted electrodes, tattoos, or piercings)

Keywords: fear cycloserine conditioning functional neuroimaging anxiety disorders
effects of upperlimb sensorimotor training in hemiplegic cerebral palsy

Conditions: Cerebral Palsy

Summary: the study aims to determine the effects of upper limb sensorimotor training as compared to task oriented raining in subjects with cerebral palsy. the study will target the upperlimb functions using multiple outcomes and will find the changes in subjects undergoing sensorimotor or task oriented training.

the stduy will include subjects fulfilling the inclusion criteria, will be divided into 2 groups; interventional and control. the interventional group will be recieving sensorimotor training comprising of sensory activities and motor activities. the control group will be having motor activities in the form of task oriented training. the duration of intervention would be 40 minutes in each group, 3 days a week, for 8 weeks.

Eligibility criteria:
inclusion criteria: * hemiplegic cerebral palsy modified ashworth scale score 2 and 3 exclusion criteria: * other neurological disorders previous upper limb surgeries botox injection in last 1 year
evaluation of a multimodal neuroimaging method for diagnosis in parkinsonian syndromes

Conditions: Parkinson's Disease; Multiple System Atrophy

Summary: based on previous promising results, the next step for the validation of a multimodal mri method in diagnosis and follow up of patients reached by parkinsonian syndromes is (i) to test whether the multimodal neuroimaging is able to discriminate at the individual level, patients with multiple system atrophy parkinsonism (msa) and patients with idiopathic parkinson's disease (pd) (ii) to determine whether the method is sensitive to measure changes over time for the two diseases, according to imaging, neuropsychological and other clinical data. patients will be compared with healthy controls.

30 patients with pd, 30 patients with msa and 30 healthy controls will be examined in a 3tesla mri. the aim of our project is to demonstrate that our multimodal mri method can discriminate both diseases with a similar clinical presentation and monitor the progress of the disease. cic's expertise in recruitment and assessment of patients, and the powers of the inserm u825 in terms of development and processing in neuroimaging guarantee the feasibility of the project and its successful completion.

Eligibility criteria:
inclusion criteria: * informed consent signed * right handed patients * mini mental score \> 22 * no other neurological disease than parkinson's disease (pd) or multiple system atrophy (msa) * non-demented patients reached by pd or msa (according to diagnosis criteria from uk pd brain bank and from gilman and colleagues, 1998, for pd and msa respectively) * for pd patients only : hoehn and yahr score from 2 to 3 exclusion criteria: * claustrophobia * contraindications to mri (cardiac or auditive prothesis, pacemakers, cerebral clip, stimulating electrodes) * pregnant women * major neuropsychiatric disease * refusal to be informed in case of cerebral anomaly detected during mri acquisition * uncompensated thyroid deficit

Keywords: differential diagnosis multimodal mri parkinson's disease multiple system atrophy
effectiveness of resin sealants: retrospective cohort study

Conditions: Dental Caries

Summary: this retrospective cohort study assessed sealant clinical success applied to pit and fissure by dental undergraduate students at piracicaba dental school - brazil.

a population presenting 1st/2nd permanent molars with sealed occlusal surfaces were considered. dental records were reviewed for: patient's caries risk (high/low); operator experience (scores 1 to 4, beginners to seniors); number of follow-up visits; isolation procedure; sealant/tooth type; and age at placement. posteriorly, the patients were called to dental evaluation and the sealed teeth were classified regarding the sealant presence, partial presence or absence, with or without caries, or sealant replacement to a restorative material in satisfactory or unsatisfactory, considering the caries presence/absence. successful outcome was considered in the caries absence.

Eligibility criteria:
inclusion criteria: * a population presenting first and second permanent molars with sealed occlusal surfaces by dental undergraduate students at piracicaba dental school brazil. exclusion criteria: * first and second permanent molars with sealed occlusal surfaces by dentistry.

Keywords: pit and fissure sealants dental caries prevention dental undergraduate students patient's caries risk
a study to evaluate the efficacy and safety of karxt + karx-ec for cognitive impairment in alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to evaluate the efficacy and safety of karxt + karx-ec for cognitive impairment in alzheimer's disease


Eligibility criteria:
inclusion criteria * participants must have a confirmed diagnosis of alzheimer's disease (ad), specifically at the mild (stage 4) or moderate (stage 5) dementia stages, as defined by the national institute on aging and alzheimer's association (nia-aa) core clinical criteria. the diagnosis of ad pathology must be confirmed through the 2024 revised nia-aa workgroup criteria using a stepwise diagnostic approach. * participants must have an mini-mental state examination (mmse) score ranging from 12 through 22, inclusive, at the time of screening. * participants must have a designated caregiver who maintains adequate contact (around 10 hours per week or more) and is willing to attend all study visits. the caregiver must also be responsible for reporting on the participant's condition, overseeing medication compliance, and consenting to their involvement in both their own and the participant's study-related activities. * participants on acetyl choline esterase inhibitors (acheis) and/or memantine, must have been on a stable dosage for at least 12 weeks prior to screening, and agree to maintain this stable dose for the study duration. exclusion criteria * participants must not present with any significant or severe medical conditions that could compromise their safety, the ability to comply with or complete the study, or the integrity of the study results. this includes any grade of hepatic impairment. * participants must not have any primary psychiatric diagnoses such as major depression, schizoaffective disorder, or bipolar disorder, and those with severe psychiatric symptoms that could complicate the interpretation of treatment effects, impair cognitive assessment, or impact study completion. * participants must not have a history of schizophrenia or other chronic psychosis, as well as those who have previously been exposed to karxt or are currently undergoing treatment with disease-modifying anti-amyloid therapies for ad within the past 6 months prior to screening. * participants must not have significant pathological findings on brain magnetic resonance imaging (mri) at screening that could affect safety or interfere with study procedures. * other protocol-defined inclusion/exclusion criteria apply.

Keywords: dementia cognitive impairment kar-xt karx-ec mild alzheimer's disease moderate alzheimer's disease
reference interval validation of high-sensitivity cardiac troponin t assay in thai population

Conditions: Diagnoses Disease

Summary: the investigators aimed to study the cut-off of high sensitivity troponin t using sysmex hlscl machine in thai population at percentile 99.


Eligibility criteria:
for healthy group inclusion criteria: * group 1: aged 18 - 40 years * group 2: aged \> 40 - 70 years * a presumably healthy population will define from a health questionnaire exclusion criteria: * heart diseases * renal diseases (ckd or recent aki) * history of pulmonary embolism for patient group with stable heart diseases inclusion criteria: * aged \> 40 - 70 years * stable heart disease individuals will be evaluated by cardiologist * non hospitalized (opd settings) exclusion criteria: * stable heart diseases with acs * renal diseases (ckd or recent aki) * history of pulmonary embolism

Keywords: acute myocardial infarction cardiac marker troponin